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NCT Number: NCT06264297

High-Voltage Pulsed Radiofrequency of the Lumbar Dorsal Root Ganglion for the Treatment of Chronic Lumbar Radicular and Neuropathic Pain; A Prospective, Doble-blinded and Randomized Controlled Trial

The management of chronic lumbar radicular and neuropathic pain is complex and the treatment success rates are low. Pulsed radiofrequency (PRF) has been described in these cases. In order to determine whether high-voltage PRF show better results than PRF a prospective, doble-blinded and randomized study is conducted in patients with chronic lumbar radicular and neuropathic pain.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location status: Recruiting

Location contact

Maria Martinez Garcia

CONTACT

[email protected]

+34650528215

maria Martinez Garcia

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients over 18 years of age.
  • Unilateral pain radiating to the lower extremity (with or without lumbar pain), which clinically corresponds to the path of the corresponding dermatomes.
  • Correlation between clinical symptoms and lesion observed by magnetic resonance imaging (MRI).
  • Radicular syndrome of three months or more of evolution.
  • Normal or pathological electromyogram (EMG).
  • Pain with neuropathic characteristics confirmed by the DN4 neuropathic pain questionnaire.
  • Patients with a previous positive block diagnosis.
  • Patients who have signed the informed consent document.

Exclusion criteria

  • Patients under 18 years of age.
  • Patients with non-radicular low back pain.
  • MRI not consistent with the patient's symptoms.
  • Patients with peripheral neuropathy of the lower extremities.
  • Patients with a history or current diagnosis of serious mental disorder.
  • Patients with moderate or severe cognitive impairment, or evidence of acute or subacute confusional syndrome.
  • Infection at the puncture site.
  • Coagulation disorders.
  • Pregnant patients.
  • Patients who refuse to sign the informed consent document.
  • Patients allergic to radiological contrast.

Treatment and study plan

Radiofrequency

Procedure

Pulsed radiofrequency (PRF) is a nonablative pain treatment that uses radiofrequency current in short high-voltage bursts, resulting in interruption of nociceptive afferent pathways. This study aims to show how the variation in radiofrequency voltage applied to the dorsal root ganglion (DRG) affects the treatment of neuropathic pain.

Primary outcomes

  1. OSWESTRY LOW BACK DISABILITY QUESTIONNAIRE

    Time frame: From enrollment to the end of treatment at 6 months

    this questionnaire has been designed to give us information as to how your back pain has affected your ability to manage everyday life

Secondary outcomes

  1. DN4 - QUESTIONNAIRE

    Time frame: From enrollment to the end of treatment at 6 months

    DN4 - QUESTIONNAIRE To estimate the probability of neuropathic pain, please answer yes or no for each item of the following four questions.

  2. Visual Numeric Scale

    Time frame: From enrollment to the end of treatment at 6 months

    ranging from 0 to 10 was used to measure pain intensity

  3. Categorical scale

    Time frame: From enrollment to the end of treatment at 6 months

    uses adjectives, such as "mild," "moderate," "severe," and excruciating," to describe pain levels.

  4. patient global impression of improvement (pgi-i) score

    Time frame: From enrollment to the end of treatment at 6 months

    is a transition scale that is a single question asking the patient to rate their urinary tract condition now, as compared with how it was prior to before beginning treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Martinez

CONTACT

[email protected]

+34650528215

Maria Martinez

CONTACT

[email protected]

650528215

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Registry information

Acronym: Radiofrequency

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 16, 2024
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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